GUEST COLUMNISTS

• How To Build An Exceptional Medical Device Biocompatibility Program

  In recent years, biocompatibility and compliance with the ISO 10993 family of standards have been an area of significant attention. Demonstrating biocompatibility is an integral part of any device development. This article explains how to integrate a biocompatibility toxicologist into your team and his/her role within the development process.

• 5 Misconceptions About Data Integrity In Pharmaceutical And Device Development & Operations

  Data integrity (DI) issues in pharma and medical devices have always been there, but in my experience as a consultant, these issues have increased in frequency more recently, thus moving them to the forefront. In this article, I explain five misconceptions about data integrity in our industry.

• 6 Key Steps For Cell Therapy Clinical Development Success

  While the simplest option for a small or emerging biotech is to outsource protocol and clinical development to a consultant or CRO, a disengaged or absent sponsor is unlikely to have its objectives realized. Prior to engaging with a consultant or CRO, you can take these six steps that are likely to leave both parties engaged in the clinical development process.

• Biotech Patenting: 4 Tips & Personal Experiences

  When you file for patent protection for your discoveries, keep these 4 tips in mind. I also share some of my personal experiences with patenting from over the course of the last 28 years, from when I cofounded 180 Life Sciences through now.

• EU MDR Postmarket Clinical Follow-Up Compliance: 3 Tips & 3 Pitfalls

  The EU MDR regulation imposes new requirements for clinical evaluation for some Class III and implantable devices, narrowing equivalence routes and placing greater emphasis on postmarket clinical follow-up (PMCF). This article provides three best practices for compliance and then offers an overview of common issues observed in notified body submissions.

• FDA Issues Final Rule On Intended Use For Drugs & Devices After A Complicated History

  On Sept. 1, 2021, the FDA’s final rule on intended use for drugs and devices became effective. The rule has a complicated history and has been the subject of controversy over the last 6 years. The final rule provides clarity to manufacturers, but many stakeholders are still unsatisfied with the evidentiary standard for determining intended use, perhaps forecasting legal challenges to the regulation.

• Harnessing Lab Deviations For Performance Transformation In Vaccine Manufacturing

  Deviations in the pharmaceutical process generally lead to non-compliance and issues meeting demand, so they require careful tracking, monitoring, and remediation. The presence of deviations may seem inevitable, yet COVID has brought to light the question of how vaccine manufacturing sites can manufacture more vaccines, more efficiently. This article explains how.

• How To Find & Manage Biotech Consultants Effectively

  The roles being filled by biotech consultants have grown considerably, as companies are becoming more familiar with working with consultants and more people are interested in pursuing a consultant career. But how do we find good consultants, and how do we ensure that our consultants are as committed and engaged as our full-time employees? Here's how to accomplish that.